Diabetes Mellitus, Type 2NCT04180813
Real-world Study Comparing the Adherence and Effectiveness of Linagliptin vs. Acarbose
An observational study of Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 10 sites in China.
Trial summary
Non-interventional cohort study based on newly collected data under routine medical practice of a total of 500 Diabetes Mellitus, Type 2 patients Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Linagliptin and Acarbose
- How many people
- 85 participants
- Where
- 10 sitesChina
- Study dates
- 4 Mar 2020to 11 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A total of 500 outpatients with T2DM from 16 sites distributed in different regions in mainland China.
Who may be able to join
- Patient should fully know and understand the content of consent form, and the patient is willing and able to sign an informed consent form
- Chinese outpatients with confirmed T2DM
- Patients of ≥ 18, < 80 years old
- Patients currently use metformin monotherapy ≥ 1500 mg/day or maximum tolerable dose and whose glucose levels are not adequately controlled
- HbA1c ≥ 7% and < 12%
- New user* linagliptin or acarbose as combination therapy with metformin ≥ 1500 mg/day or maximum tolerable dose *New user defined as a T2DM patient initiating linagliptin or acarbose as an add-on therapy.
- These are patients who are on metformin and whose glucose levels are not adequately controlled.
Who cannot join
- Type 2 diabetes mellitus patients who previously used any DPP-4 inhibitor/ GLP-1 receptor agonist at index date or any AGI at index date, are not eligible to participate. Also excluded are patients who currently using any glucose-lowering agent as monotherapy other than metformin.
- Patients with clinically significant acute major organ or systemic disease or other condition judged by the investigator that would create difficulty for the 24-week follow-up.
- Patients who participated in a clinical trial within 2 months prior to study enrolment date.
- Patients diagnosed with Type 1 diabetes mellitus, secondary diabetes or gestational diabetes.
- Current treatment with systemic steroids at time of informed consent or within 6 weeks prior to informed consent.
- Patients with known significant GI disease as judged by the study physician.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
China10 sites
No.731 Hospital of China Aerospace Science & Industry Corp.
Beijing, 100074
Affiliated Hospital of Chengdu University
Chengdu, 610081
ChongQing The Fourth Hospital
Chongqing, 400014
Dongying People's Hospital
Dongying, 257000
Huai'an first people's hospital
Huai'an, 223300
Nanjing Drum Tower Hospital
Nanjing, 210008
Zhongda Hospital Southeast University
Nanjing, 210009
Shanghai TCM-Integrated Hospital
Shanghai, 200000
Southern Medical University Shenzhen Hospital
Shenzhen, 518110
Zhangjiagang First People Hospital
Suzhou, 215699
About this study
Official title: A Non-interventional Study of Patient Medication Adherence and Treatment Effectiveness Among New Users of Linagliptin and Acarbose in the Real-world Clinical Setting in China
Non-interventional cohort study based on newly collected data under routine medical practice of a total of 500 Diabetes Mellitus, Type 2 patients
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Linagliptin, Acarbose
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LinagliptinDrug
Also called Trajenta®
drug
AcarboseDrug
drug
| Study group | Role | What they receive |
|---|---|---|
| Linagliptin Initiators | Not described Receives: Drug: Linagliptin | |
| Acarbose Initiators | Not described Receives: Drug: Acarbose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of T2DM patients with high medication adherence at Week 24
Measured: 24 weeks
Secondary outcomes (4)
The effectiveness of linagliptin and acarbose on glycemic control evaluated by reducing HbA1c during a 24 week follow-up in two groups
Measured: 24 weeks
Proportion of T2DM patients achieving a therapeutic glycemic response defined as HbA1c < 7.0% or a lowering of HbA1c ≥ 0.5%
Measured: 24 weeks
To compare the composite endpoint (proportion of achieving HbA1c < 7.0% without gastrointestinal adverse events (GI AEs) and without an investigator defined hypoglycaemic event)
Measured: 24 weeks
Patient satisfaction by Diabetes Treatment Satisfaction Questionnaire (DTSQ) among linagliptin and acarbose initiators. The DTSQ would be completed at routine physician visits since initiation of the drug
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2019
- Study start4 Mar 2020
- Primary completion11 Jul 2021
- Study completion11 Jul 2021
Why it stopped: Study enrollment did not meet expectation.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04180813
- Sponsor's protocol ID
- 1218-0184
- Status last verified
- Jun 2022
- First submitted
- 26 Nov 2019
- Last updated
- 23 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website. The data shared are the raw clinical study data sets.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-interventional Study of Patient Medication Adherence and Treatment Effectiveness Among New Users of Linagliptin and Acarbose in the Real-world Clinical Setting in China
- ClinicalTrials.gov ID
- NCT04180813
- Acronym / sponsor ID
- 1218-0184
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study enrollment did not meet expectation.
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 4 Mar 2020 (actual)
- Primary completion
- 11 Jul 2021 (actual)
- Study completion
- 11 Jul 2021 (actual)
- First posted
- 29 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Non-interventional cohort study based on newly collected data under routine medical practice of a total of 500 Diabetes Mellitus, Type 2 patients
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Linagliptin Initiators | – | Drug: Linagliptin |
| Acarbose Initiators | – | Drug: Acarbose |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 500 outpatients with T2DM from 16 sites distributed in different regions in mainland China.
Key inclusion criteria (7 listed)
- Patient should fully know and understand the content of consent form, and the patient is willing and able to sign an informed consent form
- Chinese outpatients with confirmed T2DM
- Patients of ≥ 18, < 80 years old
- Patients currently use metformin monotherapy ≥ 1500 mg/day or maximum tolerable dose and whose glucose levels are not adequately controlled
- HbA1c ≥ 7% and < 12%
Key exclusion criteria (6 listed)
- Type 2 diabetes mellitus patients who previously used any DPP-4 inhibitor/ GLP-1 receptor agonist at index date or any AGI at index date, are not eligible to participate. Also excluded are patients who currently using any glucose-lowering agent as monotherapy other than metformin.
- Patients with clinically significant acute major organ or systemic disease or other condition judged by the investigator that would create difficulty for the 24-week follow-up.
- Patients who participated in a clinical trial within 2 months prior to study enrolment date.
- Patients diagnosed with Type 1 diabetes mellitus, secondary diabetes or gestational diabetes.
- Current treatment with systemic steroids at time of informed consent or within 6 weeks prior to informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LinagliptinAlso: Trajenta®drug | Drug | Linagliptin Initiators |
| Acarbosedrug | Drug | Acarbose Initiators |
Primary outcome
Proportion of T2DM patients with high medication adherence at Week 24
Time frame: 24 weeks
4 secondary outcomes
The effectiveness of linagliptin and acarbose on glycemic control evaluated by reducing HbA1c during a 24 week follow-up in two groups
Time frame: 24 weeks
Proportion of T2DM patients achieving a therapeutic glycemic response defined as HbA1c < 7.0% or a lowering of HbA1c ≥ 0.5%
Time frame: 24 weeks
To compare the composite endpoint (proportion of achieving HbA1c < 7.0% without gastrointestinal adverse events (GI AEs) and without an investigator defined hypoglycaemic event)
Time frame: 24 weeks
Patient satisfaction by Diabetes Treatment Satisfaction Questionnaire (DTSQ) among linagliptin and acarbose initiators. The DTSQ would be completed at routine physician visits since initiation of the drug
Time frame: 24 weeks
Results and safety
The study was stopped early (reason given: Study enrollment did not meet expectation.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2022.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website. The data shared are the raw clinical study data sets.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 10 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study enrollment did not meet expectation.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of T2DM patients with high medication adherence at Week 24 (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2022.